Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr;27(4):260-264.
doi: 10.5005/jp-journals-10071-24443.

Therapeutic Drug Monitoring of Isavuconazole: Lessons Learnt from a Real-life Setting in a Tertiary Care Center in India

Parikshit Shirish Prayag  1 , Rajeev N Soman  1 , Shweta P Panchakshari  1 , Preeti S Ajapuje  1 , Namita P Mahale  2 , Surabhi Dhupad  1 , Sampada A Patwardhan  2 , Sadanand S Naik  3 , Sharwari Narawade  3 , Anand Athavale  4 , Sanjith Saseedharan  5 , Sameer Melinkeri  6 , Amrita P Prayag  7
Affiliations

Therapeutic Drug Monitoring of Isavuconazole: Lessons Learnt from a Real-life Setting in a Tertiary Care Center in India

Parikshit Shirish Prayag et al. Indian J Crit Care Med. 2023 Apr.

Abstract

Introduction: Isavuconazole is an emerging therapeutic option for invasive infections caused by molds, especially aspergillosis and mucormycosis. Isavuconazole has predictable pharmacokinetics and good bioavailability. These attributes have led to some doubts regarding the need for therapeutic drug monitoring (TDM). There are no data from India regarding TDM for isavuconazole.

Methods: A retrospective analysis of 50 patients who received oral isavuconazole for therapeutic purposes. Plasma isavuconazole levels were measured using a reversed phase high-performance liquid chromatography (HPLC) and UV detector with acetonitrile (ACN) as protein precipitating solvent.

Results: Of the 50 cases, 5 (10.0%) patients had subtherapeutic levels, while 45 (90.0%) had therapeutic levels. Higher body weight and solid organ transplantation (SOT) were significantly associated with subtherapeutic levels of isavuconazole (p-value < 0.05 for all). Receipt of a SOT was the only independent and statistically significant factor which was associated with subtherapeutic levels of isavuconazole (p-value < 0.05).

Conclusion: Our study reemphasizes the need of TDM for isavuconazole and adds to the growing evidence for the need to obtain drug levels. Factors associated with subtherapeutic levels of isavuconazole need to be assessed in larger studies to help identify those patients who are at risk of having subtherapeutic drug levels.

How to cite this article: Prayag PS, Soman RN, Panchakshari SP, Ajapuje PS, Mahale NP, Dhupad S, et al. Therapeutic Drug Monitoring of Isavuconazole: Lessons Learnt from a Real-life Setting in a Tertiary Care Center in India. Indian J Crit Care Med 2023;27(4):260-264.

Keywords: Aspergillosis; Drug monitoring; Fungal infections; Fungus; Isavuconazole; Mold infections; Mucormycosis; Therapeutic drug monitoring.

PubMed Disclaimer

Conflict of interest statement

Source of support: Nil Conflict of interest: None

Figures

Flowchart 1
Flowchart 1
Patient enrolment: included 50 patients who received oral isavuconazole for therapeutic purposes. Patients were excluded if levels were drawn within 5 days of starting therapy, patients were taking doses other than the standard recommended dose of oral isavuconazole, if levels were not appropriately timed, or if patients were not compliant with therapy
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Cornely OA, Alastruey-Izquierdo A, Arenz D, Chen SC, Dannaoui E, Hochhegger B, et al. Global guideline for the diagnosis and management of mucormycosis: An initiative of the European Confederation of Medical Mycology in cooperation with the Mycoses Study Group Education and Research Consortium. Lancet Infect Dis. 2019;19(12):e405–e421. doi: 10.1016/S1473-3099(19)30312-3. - DOI - PMC - PubMed
    1. Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, et al. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): A phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016;387(10020):760–769. doi: 10.1016/S0140-6736(15)01159-9. - DOI - PubMed
    1. McCarthy MW, Moriyama B, Petraitiene R, Walsh TJ, Petraitis V. Clinical pharmacokinetics and pharmacodynamics of isavuconazole. Clin Pharmacokinet. 2018;57(12):1483–1491. doi: 10.1007/s40262-018-0673-2. - DOI - PubMed
    1. Patterson TF, Thompson III GR, Denning DW, Fishman JA, Hadley S, Herbrecht R, et al. Practice guidelines for the diagnosis and management of aspergillosis: 2016 update by the infectious diseases society of America. Clin Infect Dis. 2016;63(4):e1–e60. doi: 10.1093/cid/ciw326. - DOI - PMC - PubMed
    1. Andes D, Kovanda L, Desai A, Kitt T, Zhao M, Walsh TJ. Isavuconazole concentration in real-world practice: Consistency with results from clinical trials. Antimicrob Agents Chemother. 2018;62(7):e00585–e005818. doi: 10.1128/AAC.00585-18. - DOI - PMC - PubMed